NCT03612999

Brief Summary

To learn about individual glycemic response to physiological and psychological conditions across a diverse population, the investigators will collect sensor and lifestyle data directly from participants as they engage in daily activities. The investigators will collect real-time glucose data from a continuous glucose monitor (CGM) system; accelerometer, aggregated activity, and sleep data from a wrist-worn activity tracker; mood and experiential data; and food information. Non-sensor data will be collected using a paper log, or via a study app when available.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 31, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2020

Completed
Last Updated

March 17, 2021

Status Verified

September 1, 2020

Enrollment Period

2.3 years

First QC Date

July 23, 2018

Last Update Submit

March 15, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Glucose Level (mg./dl.)

    Estimated glucose concentration (mg./dl.) sampled every five minutes by a continuous glucose monitor (CGM).

    20 days per participant

Secondary Outcomes (6)

  • Activity level (steps per hour)

    20 days per participant

  • Food Consumption (type and quantity)

    20 days per participant

  • Activities of daily living (free form)

    20 days per participant

  • Psychological state (free-form)

    20 days per participant

  • Sensor wear time (wear / no-wear intervals)

    20 days per participant

  • +1 more secondary outcomes

Study Arms (1)

CGM and Activity Tracker

EXPERIMENTAL

Subjects receive a continuous glucose monitor (CGM) and activity tracker and are instructed to record daily activities and psychological data.

Device: Dexcom continuous glucose monitorDevice: Fitbit activity trackerBehavioral: Subjects record daily activityBehavioral: Subjects record psychological state

Interventions

Dexcom continuous glucose monitorDEVICE

Continuous glucose monitors (CGMs) record subjects glucose levels

CGM and Activity Tracker
Fitbit activity trackerDEVICE

Activity trackers will record subjects' physical activity, heart rate, and sleep.

CGM and Activity Tracker
Subjects record daily activityBEHAVIORAL

Subjects will record their daily activities, either on paper or on a secure texting app.

CGM and Activity Tracker
Subjects record psychological stateBEHAVIORAL

Subjects will record their psychological state, either on paper or on a secure texting app.

CGM and Activity Tracker

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be at least 18 years old
  • Be able to read, speak, and understand English
  • Have a primary care provider

You may not qualify if:

  • Not receive or require kidney dialysis
  • Not be pregnant
  • Not have type 1 diabetes
  • Not have type 2 diabetes and be prescribed three or more daily injections of insulin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Savvysherpa, LLC

Minnetonka, Minnesota, 55343, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2018

First Posted

August 2, 2018

Study Start

May 31, 2018

Primary Completion

September 23, 2020

Study Completion

September 23, 2020

Last Updated

March 17, 2021

Record last verified: 2020-09

Locations

US(1)